PCa tumor volume, grade on the rise post-USPSTF

Dr. KapoorResults of a recent study raise new concerns about the U.S. Preventive Services Task Force’s grade “D” recommendation against PSA screening and a proposed quality measure financially penalizing physicians for “unnecessary screening for prostate cancer using PSA.”

The large, single-institution, retrospective study examined trends in histology of newly diagnosed prostate cancer.

Related: Are you seeing a decline in PSA screening?

The research, presented by Deepak A. Kapoor, MD, and colleagues at the Genitourinary Cancers Symposium in San Francisco, compared features of prostate biopsies performed post-USPSTF in 2013, 2014, and 2015 (through October) with those done pre-USPSTF in 2010-2011. The post-USPSTF and pre-USPSTF cohorts were similar in mean age and average number of cores taken.

The histologic analyses, however, showed that both the percentage of positive biopsies and the aggressiveness of diagnosed prostate cancer increased during the post-USPSTF period.

Next: Diagnosis rate, percentage of men diagnosed with Gleason 8-10 disease see increases

The prostate cancer diagnosis rate increased from 39.7% in 2010-2011 to 41.4% in 2013 and 45.4% in 2015. The percentage of positive cores per positive prostate biopsy rose from 31.4% in the pre-USPSTF cohort to 33.3% in 2015, and the percentage of men diagnosed with Gleason 8-10 cancers increased from 15.5% in 2010-2011 to 24.5% in 2015.

Read: AUA, others fight measure penalizing docs who order PSA

In addition, analyses of two novel endpoints for stratifying risk, one reflecting Gleason score and number of cores positive and the other reflecting Gleason pattern and number of cores positive, showed changes by 2013 that became significant in 2014 and remained so in 2015.

Dr. Kapoor is chairman and chief executive officer of Integrated Medical Professionals and associate clinical professor of urology at Icahn School of Medicine at Mount Sinai, New York, and chairman of health policy for LUGPA. He spoke to Urology Times about the study and actions LUGPA is taking to address the USPSTF recommendation and the draft electronic clinical quality measure (ECQM), developed by Mathematica Policy Research for the Centers for Medicare & Medicaid Services contractor.

What does your study add to our understanding of the impact of the USPSTF recommendation on trends in prostate cancer diagnosis?

There have been studies analyzing data from either Surveillance, Epidemiology, and End Results or single institutions documenting a shift toward diagnosis of higher risk prostate cancers after 2012. Our findings are consistent with those reports, but our study has some unique strengths.

Also see: Why urology residents should care about health policy

Unlike the studies using SEER data, where there may be confounding due to changes over time in the composition of the providers and patients, our study derives from a single institution where the providers, clinical protocols, and practice demographics were constant. In addition, our study of almost 12,000 men is by far the largest single-institution study on this subject.

Next: Findings are "extremely disconcerting"

What are the take-home messages from your study and related research on this topic?

The results are extremely disconcerting because they indicate that newly diagnosed cancers are presenting with increased tumor volume and grade, which may translate into an increase in prostate cancer-related mortality; unfortunately, we may not see that effect for another 5 to 10 years. Although we can’t establish an absolute causal link to USPSTF from a single study, it is absolutely astonishing to see that the migration to more aggressive disease has happened so quickly after the recommendation-particularly since our protocols have been stable. While we didn’t specifically study this, evidence from other recent studies shows an increase in the percentage of disseminated disease at diagnosis since the USPSTF recommendation, which is very ominous.

The simple fact is that prostate cancer remains the second leading cause of cancer deaths in men. It’s very premature for CMS to be codifying the USPSTF recommendation into law at this point in time when alarm bells are ringing.

How is LUGPA addressing the prostate cancer screening issue?

We are encouraged by the fact that the USPSTF announced last year that it will begin reviewing its recommendation for PSA testing, and the LUGPA is part of a coalition with the American Urological Association and the American Association of Clinical Urologists that is working with the USPSTF to reform the 2012 guideline. To that end, we have submitted documentation summarizing relevant research. In addition, we have submitted comments to CMS regarding the draft ECQM. (To read these documents, click here.)

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